Raphael E. Cuomo

Emerging and Reemerging Neglected Tropical Diseases: a Review of Key Characteristics, Risk Factors, and the Policy and Innovation Environment

SUMMARY In global health, critical challenges have arisen from infectious diseases, including the emergence and reemergence of old and new infectious diseases. Emergence and reemergence are accelerated by rapid human development, including numerous changes in demographics, populations, and the environment. This has also led to zoonoses in the changing human-animal ecosystem, which are impacted by a growing globalized society where pathogens do not recognize geopolitical borders. Within this context, neglected tropical infectious diseases have historically lacked adequate attention in international public health efforts, leading to insufficient prevention and treatment options. This subset of 17 infectious tropical diseases disproportionately impacts the worlds poorest, represents a significant and underappreciated global disease burden, and is a major barrier to development efforts to alleviate poverty and improve human health. Neglected tropical diseases that are also categorized as emerging or reemerging infectious diseases are an even more serious threat and have not been adequately examined or discussed in terms of their unique risk characteristics. This review sets out to identify emerging and reemerging neglected tropical diseases and explore the policy and innovation environment that could hamper or enable control efforts. Through this examination, we hope to raise awareness and guide potential approaches to addressing this global health concern.

Establishing a Link Between Prescription Drug Abuse and Illicit Online Pharmacies: Analysis of Twitter Data

Background Youth and adolescent non-medical use of prescription medications (NUPM) has become a national epidemic. However, little is known about the association between promotion of NUPM behavior and access via the popular social media microblogging site, Twitter, which is currently used by a third of all teens. Objective In order to better assess NUPM behavior online, this study conducts surveillance and analysis of Twitter data to characterize the frequency of NUPM-related tweets and also identifies illegal access to drugs of abuse via online pharmacies. Methods Tweets were collected over a 2-week period from April 1-14, 2015, by applying NUPM keyword filters for both generic/chemical and street names associated with drugs of abuse using the Twitter public streaming application programming interface. Tweets were then analyzed for relevance to NUPM and whether they promoted illegal online access to prescription drugs using a protocol of content coding and supervised machine learning. Results A total of 2,417,662 tweets were collected and analyzed for this study. Tweets filtered for generic drugs names comprised 232,108 tweets, including 22,174 unique associated uniform resource locators (URLs), and 2,185,554 tweets (376,304 unique URLs) filtered for street names. Applying an iterative process of manual content coding and supervised machine learning, 81.72% of the generic and 12.28% of the street NUPM datasets were predicted as having content relevant to NUPM respectively. By examining hyperlinks associated with NUPM relevant content for the generic Twitter dataset, we discovered that 75.72% of the tweets with URLs included a hyperlink to an online marketing affiliate that directly linked to an illicit online pharmacy advertising the sale of Valium without a prescription. Conclusions This study examined the association between Twitter content, NUPM behavior promotion, and online access to drugs using a broad set of prescription drug keywords. Initial results are concerning, as our study found over 45,000 tweets that directly promoted NUPM by providing a URL that actively marketed the illegal online sale of prescription drugs of abuse. Additional research is needed to further establish the link between Twitter content and NUPM, as well as to help inform future technology-based tools, online health promotion activities, and public policy to combat NUPM online.

Exploring the e-cigarette e-commerce marketplace: Identifying Internet e-cigarette marketing characteristics and regulatory gaps.

BACKGROUND The electronic cigarette (e-cigarette) market is maturing into a billion-dollar industry. Expansion includes new channels of access not sufficiently assessed, including Internet sales of e-cigarettes. This study identifies unique e-cigarette Internet vendor characteristics, including geographic location, promotional strategies, use of social networking, presence/absence of age verification, and consumer warning representation. METHODS We performed structured Internet search engine queries and used inclusion/exclusion criteria to identify e-cigarette vendors. We then conducted content analysis of characteristics of interest. RESULTS Our examination yielded 57 e-cigarette Internet vendors including 54.4% (n=31) that sold exclusively online. The vast majority of websites (96.5%, n=55) were located in the U.S. Vendors used a variety of sales promotion strategies to market e-cigarettes including 70.2% (n=40) that used more than one social network service (SNS) and 42.1% (n=24) that used more than one promotional sales strategies. Most vendors (68.4%, n=39) displayed one or more health warnings on their website, but often displayed them in smaller font or in their terms and conditions. Additionally, 35.1% (n=20) of vendors did not have any detectable age verification process. CONCLUSIONS E-cigarette Internet vendors are actively engaged in various promotional activities to increase the appeal and presence of their products online. In the absence of FDA regulations specific to the Internet, the e-cigarette e-commerce marketplace is likely to grow. This digital environment poses unique challenges requiring targeted policy-making including robust online age verification, monitoring of SNS marketing, and greater scrutiny of certain forms of marketing promotional practices.

Could vitamin D sufficiency improve the survival of colorectal cancer patients

PURPOSE To determine whether a higher serum 25-hydroxyvitamin D [25(OH)D] concentration at diagnosis is associated with longer survival of colorectal cancer patients. METHODS A meta-analysis was performed of studies of the relationship between 25(OH)D and mortality of patients with colorectal cancer. A random-effects model was used to calculate a pooled hazards ratio. Homogeneity was evaluated through a DerSimonian-Laird test. RESULTS Higher serum concentrations of 25(OH)D were associated with lower mortality in patients with colorectal cancer. Patients in the highest quintile of 25(OH)D had 37% lower mortality from colorectal cancer compared to those in the lowest quintile of 25(OH)D (pooled odds ratio=0.63, p<0.0001). Dose-response curves showed lower hazard ratios for mortality with higher serum 25(OH)D through at least 40ng/ml. There were no exceptions. CONCLUSIONS Higher serum 25(OH)D was associated with lower mortality of patients with colorectal cancer. These results suggest that colorectal cancer patients with deficient levels of serum 25(OH)D should have their levels restored to a normal range (30-80ng/ml). This could be done with regular testing of serum 25(OH)D to be confident that an adequate serum level is being maintained. Additional studies would be worthwhile to evaluate confounding or the possibility of reverse causation.

After counterfeit Avastin ® —what have we learned and what can be done?

Three years have passed since the FDA announced that it had detected counterfeit versions of the injectable anticancer drug bevacizumab (Avastin®, Genentech, USA) in the US drug-supply chain. Following this discovery, almost 1,000 FDA warning letters were sent to physicians and medical practices in 48 different states and two US territories, as more batches of counterfeit Avastin were uncovered. In response, criminal prosecutions have been pursued against certain distributors and clinicians, and other individuals who trafficked, sold, purchased, and/or administered an unsafe and ineffective treatment while also defrauding the government. Although limited and targeted legal action has been taken, patients potentially affected by this seminal patient safety event have not been appropriately identified. Hence, despite the clear and documented patient-safety and public-health risks posed by the transnational criminal trade in counterfeit medicines, the case study of counterfeit bevacizumab detection in the USA demonstrates the continued lack of information, knowledge, and solutions that would be necessary to protect those who are most affected—the patients. In response, we call for greater investment in multisector, multistakeholder strategies to enhance surveillance for counterfeit medicines and enable improvements in communication of risk information, to better protect patients with cancer.

What is the relationship between ultraviolet B and global incidence rates of colorectal cancer

The purpose of this study is to examine the relationship between ultraviolet B and global incidence of colorectal cancer, while controlling for relevant covariates. Linear regression was used to assess the relationship between latitude and incidence rates of colon cancer in 173 countries. Multiple linear regression was employed to investigate the relationship between ultraviolet B dose and colorectal cancer rates while controlling for per capita intake of energy from animal sources, per capita health expenditure, pigmentation, and life expectancy. Data on all variables were available for 139 countries. Incidence of colon cancer was highest in countries distant from the equator (R2 = 0.50, p < 0.0001). UV B dose (p < 0.0001) was independently, inversely associated with incidence rates of colorectal cancer after controlling for intake of energy from animal sources, per capita health expenditure, pigmentation, and life expectancy (R2 for overall model = 0.76, p < 0.0001). Consistent with previous research, UVB was inversely associated with incidence of colon cancer. Further research on vitamin D and prevention of colon cancer in individuals should be conducted, including studies of higher serum 25-hydroxyvitamin D concentrations than have been studied to date.

Pricing and sales tax collection policies for e-cigarette starter kits and disposable products sold online.

BACKGROUND Previous studies have examined marketing characteristics of e-cigarettes sold online and others have examined e-cigarettes pricing in retail (non-Internet) settings. This study expands on these findings by examining pricing and marketing characteristics of interest among e-cigarette online vendors. METHODS Structured web searches were conducted from August-September 2014 to identify popular e-cigarette Internet vendors. We then collected pricing data (e-cigarette starter kits and disposables), sales tax collection policies and other vendor marketing characteristics. Average price for each product category was then compared with marketing characteristics using linear regression for continuous variables and independent t-tests for binary variables. RESULTS Our searches yielded 44 e-cigarette Internet vendors of which 77% (n = 34) sold a total of 238 starter kit offerings (Mprice = 

An exploration of counterfeit medicine surveillance strategies guided by geospatial analysis: lessons learned from counterfeit Avastin detection in the US drug supply chain

55.89). Half (n = 22) sold disposable types of e-cigarettes (Mprice = 

Are low ultraviolet B and vitamin D associated with higher incidence of multiple myeloma

7.17 p/e-cigarette) at a price lower than reported elsewhere in retail settings. Average disposable e-cigarette prices were also significantly higher for vendors displaying more health warning notices (P = 0.001). Only 46% disclosed sales tax collection policies and only 39% collected sales tax in their state of business. CONCLUSIONS This study expands on current understanding of e-cigarette pricing and availability online and finds variation in e-cigarette pricing may be influenced by type of product, use of online health warnings and vendor sales tax collection policies. It also finds that e-cigarette online access and availability may be impacted by a combination of pricing and marketing strategies uniquely different from e-cigarette retail settings that requires further study and targeted policy-making. [Cuomo RE, Miner A, Mackey TK. Pricing and sales tax collection policies for e-cigarette starter kits and disposable products sold online. Drug Alcohol Rev 2015].

The economics of counterfeit Avastin: a geospatial and statistical analysis of demographic correlates to FDA warning letters

Objective To explore healthcare policy and system improvements that would more proactively respond to future penetration of counterfeit cancer medications in the USA drug supply chain using geospatial analysis. Design A statistical and geospatial analysis of areas that received notices from the Food and Drug Administration (FDA) about the possibility of counterfeit Avastin penetrating the US drug supply chain. Data from FDA warning notices were compared to data from 44 demographic variables available from the US Census Bureau via correlation, means testing and geospatial visualisation. Results were interpreted in light of existing literature in order to recommend improvements to surveillance of counterfeit medicines. Setting/participants This study analysed 791 distinct healthcare provider addresses that received FDA warning notices across 30 431 zip codes in the USA. Outcomes Statistical outputs were Pearsons correlation coefficients and t values. Geospatial outputs were cartographic visualisations. These data were used to generate the overarching study outcome, which was a recommendation for a strategy for drug safety surveillance congruent with existing literature on counterfeit medication. Results Zip codes with greater numbers of individuals age 65+ and greater numbers of ethnic white individuals were most correlated with receipt of a counterfeit Avastin notice. Geospatial visualisations designed in conjunction with statistical analysis of demographic variables appeared more capable of suggesting areas and populations that may be at risk for undetected counterfeit Avastin penetration. Conclusions This study suggests that dual incorporation of statistical and geospatial analysis in surveillance of counterfeit medicine may be helpful in guiding efforts to prevent, detect and visualise counterfeit medicines penetrations in the US drug supply chain and other settings. Importantly, the information generated by these analyses could be utilised to identify at-risk populations associated with demographic characteristics. Stakeholders should explore these results as another tool to improve on counterfeit medicine surveillance.